Listen-Can We Clear Something Up About Clinical Trials
Now, if you feel I am wrong; you need to tell me specifically why. My base of knowledge is pretty decent in this area. I see OSIR longs saying that they have already run 'Clinical's'. And how these 'trials' showed some amazing results. And I am not disputing OR agreeing with the results. Then the longs make a leap and say that OSIR can show this to the FDA and this will move the process along greatly. Now look. I think this is completely wrong and just silly. You can throw out your past results. Those were 'studies' that OSIR had performed for 'Marketing' purposes. They were not designed with FDA input, for the approval process for a new drug application. It is my understanding the FDA is going to make OSIR go through the New Dug Approval process for certain products. That would mean you are back at square one. The FDA has to be part of the process. You have to let them know and ask for any input into how the clinical trials should be designed. Now do you understand you kool-aide drinking side-winders...
You need to get out of the box that you have placed yourself in and think more broadly. The writing was on the wall that this FDA crackdown was coming and Mills knew it. Why do you think the Protocol 302 trial took so long to set up and execute. Maybe Mills discussed Protocol 302 with the FDA prior to starting the trial. We dont know. But we know that the press release says OSIR will leverage 302 data for the BLA. You have to believe this was the main subject of the discussion between OSIR and FDA, and ultimately ended up in the agreement. Think about, why would the FDA allow grafix to remain on the market if they knew the BLA was 2 plus years away. Think.
The 4 Products are listed at the end of this FDA Statement From: Sept 26, 2013 Letter To Osiris !
Your Ovation® product does not meet the minimal manipulation criterion set forth in 21 CFR 1271.3(f)(1) because your manufacturing process alters the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement. The original relevant characteristics of the structural tissue are altered significantly by the processing, which includes collagenase digestion of the chorionic membrane, subsequent mincing of the membrane fragments, forcing of the resulting homogenous tissue paste through an 18 gauge needle, and combining with viable cells from the same donor.
In addition, Ovation® and your products, Grafix PRIME®, Grafix CORE®, and Grafix XCTM, do not meet the criterion in 21 CFR 1271.10(a)(4)(ii) because the products are dependent upon
There is no way these products won't be approved as the majority have been in use for some time. Not to mention product candidates will be serving billion dollar markets. Despite, the shorts led by AF, who by the way may soon be wearing crow colors and feeling the love in a 4 wide, OSIR's former market cap will return. The sell of is orchestrated my the usual manipulators of words and trade who ride without SEC impunity. Because, all were talking about is an FDA approval timeline push-out, not the practical use and efficacy of products on treating large patient populations.